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Serving leading biopharmaceutical companies globally:

US Department of Justice
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Generated: December 15, 2017

DrugPatentWatch Database Preview

Details for Patent: 8,481,078

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Which drugs does patent 8,481,078 protect, and when does it expire?


Patent 8,481,078 protects FENOGLIDE and is included in one NDA. There has been one Paragraph IV challenge on Fenoglide.

This patent has twenty-nine patent family members in eleven countries.

Summary for Patent: 8,481,078

Title:Solid dosage form comprising a fibrate
Abstract: The invention provides stable, solid dosage forms and pharmaceutical compositions in particulate form comprising a fibrate, for example fenofibrate, dissolved in an non-aqueous vehicle in order to ensure improved bioavailability of the active ingredient upon oral administration relative to known fibrate formulations.
Inventor(s): Holm; Per (Vanlose, DK), Norling; Tomas (Lyngby, DK)
Assignee: Veloxis Pharmaceuticals A/S (Horsholm, DK)
Application Number:13/315,030
Patent Claim Types:
see list of patent claims
Composition; Dosage form; Formulation; Use;

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Patented / Exclusive Use
Santarus IncFENOGLIDEfenofibrateTABLET;ORAL022118-001Aug 10, 2007ABRXYesNo► Subscribe► Subscribe► SubscribeYUSE OF FENOFIBRATE FOR REDUCING ELEVATED TOTAL CHOLESTEROL (TOTAL-C), LDL-C, APO-LIPOPROTEIN B, OR TOTAL TRIGLYCERIDES
Santarus IncFENOGLIDEfenofibrateTABLET;ORAL022118-002Aug 10, 2007ABRXYesYes► Subscribe► Subscribe► SubscribeYUSE OF FENOFIBRATE FOR REDUCING ELEVATED TOTAL CHOLESTEROL (TOTAL-C), LDL-C, APO-LIPOPROTEIN B, OR TOTAL TRIGLYCERIDES
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Non-Orange Book Patents for Patent: 8,481,078

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
7,658,944Solid dosage form comprising a fibrate► Subscribe
9,173,847Tablet comprising a fibrate► Subscribe
8,124,125Solid dosage form comprising a fibrate► Subscribe
7,772,273Stabilized atorvastatin► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Patent: 8,481,078

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Russian Federation2343905► Subscribe
Russian Federation2006115596► Subscribe
South Korea20130103818► Subscribe
MexicoPA06003813► Subscribe
South Korea20060085686► Subscribe
South Korea20060085682► Subscribe
Japan2007508249► Subscribe
Japan5069001► Subscribe
Japan2007508248► Subscribe
Hong Kong1096034► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Serving leading biopharmaceutical companies globally:

Julphar
Moodys
Federal Trade Commission
Covington
Argus Health
US Army
Chubb
Accenture
Novartis
Healthtrust

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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